Pcn271 New Treatments for Malignant Advanced Melanoma for Adult Patients in Tunisia: Ineas Hta Report and Impact on Reimbursement Decision

Abstract

Objectives: Malignant melanoma is the most serious form of skin cancer. The prognosis for patients at metastatic or unresectable stage remains poor. Dacarbazine is the standard of care in Tunisia despite low response rates. INEAS, the Tunisian HTA body has just finalized, at the national payer's request, an HTA report aiming to inform reimbursement decision for two new drugs as monotherapies for advanced melanoma in adults ; nivolumab and vemurafenib (only for BRAF V600 mutationpositive patients). Methods: A review of HTA reports and systematic reviews was conducted to synthesize clinical evidence. A Cost utility analysis was performed through collaboration between INEAS and IECS, to estimate costs and QALYs from a healthcare perspective with different treatment scenarios ; 1-All population under dacarbazine, 2-All population under nivolumab 3-Population with BRAF V600 mutation under vemurafenib and population without mutation under dacarbazine, 4-Population with BRAF V600 mutation under vemurafenib and population without mutation under nivolumab. A survey among INAHTA members resulted also in collecting relevant pricing and reimbursement information. Results: The two drugs significantly improve PFS and OS compared to dacarbazine. Nivolumab has a higher probability of good performance for OS and a lower probability of severe adverse events than other alternatives. Cost utility analysis has shown that scenario 4 (nivolumab+vemurafenib) is dominated by scenario 2 (nivolumab for all). 3rd scenario is less costly but less effective than the nivolumab scenario. The ICER of scenario 2 against first scenario is around 20 times the GDPPC. Sensitivity analysis has shown that OS hazard ratios and acquisition prices were the most influential parameters on results. Important price cuts on these drugs would be necessary to be cost effective at what has been considered a reasonable WTP in Tunisia. Conclusions: These recommendations demonstrate the central role of INEAS as an HTA body in supporting evidence based decision and in facilitating access to innovation.